Comparing induction of labor versus expectant management for gestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial aims to evaluate the feasibility of a multicenter randomized controlled approach to determine if inducing labor at 38 weeks for individuals with gestational diabetes mellitus (GDM) can reduce severe perinatal complications compared to expectant management. Participants will be recruited between 36 and 38 weeks of gestation and randomly assigned to either induction of labor or expectant management until spontaneous labor. The study will involve three visits: enrollment and randomization, postpartum assessment, and a follow-up at six weeks postpartum.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of GDM after 24 weeks of gestation, based on documented 1-step or 2-step screening and diagnostic tests for GDM.
* Singleton fetus at randomization.
* Confirmed live fetus within 24 hours prior to randomization.
* Gestational age between 36 weeks + 0 days and 38 weeks + 0 days inclusive based on an ultrasound in the first or second trimester \[≤ 23 weeks + 0 days\]. For pregnancies conceived by in vitro fertilization, dating will be based on the embryo age at transfer.
* Cephalic presentation.
* Planning to deliver at a participating site.
* Aged 16 years or older.

Exclusion Criteria:

* Pre-pregnancy diabetes mellitus.
* Any obstetrical/maternal indication for immediate delivery including placenta abruption, abnormal fetal well-being either by non-stress test or biophysical profile, history of venous thromboembolism (VTE) on low molecular weight heparin, pre-existing hypertension, gestational hypertension, preeclampsia, eclampsia, or Hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome at the time of randomization.
* Contraindication to labour and/or vaginal delivery.
* Signs of labour (regular uterine contractions accompanied by cervical dilation and/or effacement) at the time of randomization.
* Significant vaginal bleeding or ruptured membranes at the time of randomization.
* Prior Cesarean delivery.
* Placenta previa, placenta accreta, or vasa previa.
* Cerclage in current pregnancy.
* Known major fetal anomaly (e.g., gastroschisis, congenital heart defects).
* Known oligohydramnios (AFI \< 5 or MVP \< 2 or no 2 by 2 pocket).
* Known fetal growth restriction (EFW \< 3rd percentile).
* Refusal of blood products.
* Use of unregulated substances.

Where it's running

• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Mark C Walker, MD, MSc, MHM — Ottawa Hospital Research Institute
• Study coordinator: Malia Murphy, PhD
• Email: malmurphy@ohri.ca
• Phone: 613-737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.